Agenda – Day III

SUMMIT PRESENTATIONS
Speaker presentations are password protected for 90 days from the start of the Summit. Registrants may log in by clicking here. For further information, email registration@hcconferences.com or call 800-503-8171.

Roeland Van Aelst joined Johnson & Johnson in 1987 as a Medical Representative for Janssen Pharmaceutica. He held various positions of increasing responsibility in both sales and marketing and joined the Corporate Office of Health Care Compliance in May 2005 for the EMEA region with extension to Asia, Latin-America and Canada in 2008. In 2010 Roeland became responsible for EMEA & Canada cross sector. Since October 2012 he is the Regional Vice President – HCCO MD EMEA. Today he also fulfills the Chairman role of the MedTech Europe Ethics and Compliance Committee. He is a member of the board and a founding member of ETHICS, an association for Compliance professionals in the Health Care industry. Roeland is an active contributor to the Seton Hall/ Sience Poand the INSEAD training programs for Compliance professionals and is co-chairman for the International Pharmaceutical and Medical Device Compliance Congress.

8:40 am

IFPMA Keynote Speech

Thomas Cueni is Director General of IFPMA since 1 February 2017. Prior to joining IFPMA he was Secretary General of Interpharma, the association of pharmaceutical research companies in Switzerland. For many years Thomas Cueni has been involved in the work of the European Federation of Pharmaceutical Industries and Associations, EFPIA, where he most recently served as Vice-Chair of the European Markets Committee and association representative on the Board. He represented the industry on the EU High Level Pharmaceutical Forum, was Chairman of EFPIA’s Economic and Social Policy Committee and Chairman of the EFPIA Task Force on the EU Commission’s Pharmaceutical Sector Inquiry. Thomas Cueni also represented Interpharma, which he successfully transformed from the association of Swiss Rx companies to the association of pharmaceutical research companies in Switzerland, on the Council of IFPMA.

9:10 am

Clinical Data Transparency: The EMA Experience

Aleksandar Rusanov is a Legal Adviser in the Legal Department of the European Medicines Agency (EMA). Since he joined in April 2014, he is dealing with various legal issues relating to the activities of the EMA including access to documents, transparency, proactive publication of clinical data, referrals, advanced therapy medicinal products, sharing of confidential information, pharmacovigilance, clinical trials, medical devices, etc. Before joining the EMA, Aleksandar was an associate in the Life Sciences team of a leading international law firm and advised clients on a wide range of matters relating to medicinal products and medical devices. Aleksandar was also seconded to a number of pharmaceutical companies to assist in activities relating to compliance, pharmacovigilance, as well as promotion and advertising of medicinal products.

Prior to joining Daiichi Sankyo Europe and starting his career in the pharmaceutical industry in 2007 Martin has been working as legal practitioner and legal in-house counsel for Amadeus in Germany advising around various legal matters and a focus on contracting in the IT/Travel Industry. In his current role as General Counsel and Chief Compliance Officer for Daiichi Sankyo in the EMEA region, Martin holds responsibility for the areas of Legal Affairs, Intellectual Property, Internal Audit & Risk Management as well as Compliance including the implementation of the company’s European Compliance Program. Martin holds a German law degree from the University of Munich and a M.B.A. in General Management from Steinbeis School of International Business and Entrepreneurship.

Aleksandar Rusanov is a Legal Adviser in the Legal Department of the European Medicines Agency (EMA). Since he joined in April 2014, he is dealing with various legal issues relating to the activities of the EMA including access to documents, transparency, proactive publication of clinical data, referrals, advanced therapy medicinal products, sharing of confidential information, pharmacovigilance, clinical trials, medical devices, etc. Before joining the EMA, Aleksandar was an associate in the Life Sciences team of a leading international law firm and advised clients on a wide range of matters relating to medicinal products and medical devices. Aleksandar was also seconded to a number of pharmaceutical companies to assist in activities relating to compliance, pharmacovigilance, as well as promotion and advertising of medicinal products.

Listed as a “leading authority” on EU Life Sciences law by Who’s Who Legal: Life Sciences 2015 Elisabethann Wright has been practising in the Life Sciences sector for over 30 years in both private practice and international institutions. Her role includes assisting clients in the classification of their products, the establishment of a pathway to authorisation and marketing of their products in the EU (including related regulatory obligations), pharmacovigilance obligations, promotion and marketing of products, sales agreements, clinical trial agreements, adverse event reporting, product withdrawals, data privacy obligations, and conduct of compliance and anti-bribery investigations.

Elisabethann Wright also has experience in litigation before the European Court of Justice, the European Court of First Instance, and the European Free Trade Agreement (EFTA) Court. Elisabethann was a R…f…rendaire (Law Clerk) at the Court of Justice of the European Communities for a number of years.

David AndersenPartner, Pharmaceuticals and Life Sciences, PwC, London, UK (Moderator)

Speaker Bio

David Andersen is a Partner in our Risk Assurance Practice in London where he leads our team focusing on Governance, Risk and Compliance advisory and assurance services for the Pharmaceutical Sector. He also sits on the UK Governance, Risk & Compliance leadership team as the compliance subject matter expert. David’s Governance, Risk & Compliance experience includes: Design and management of regulatory compliance improvement programmes; Risk assessment and control framework design and implementation; Restructuring of global and regional governance and risk functions; designing and leading a global regulatory audit function; developing and deploying risk and control monitoring programmes for both clients internal operations and their 3rd party agents.

10:45 am

Networking Break

11:15 am

EFPIA Keynote Speech

Ms Pickaert is the Deputy Director General of EFPIA, member of EFPIA’s General Management.

Since 2008, Ms Pickaert is coordinating EFPIA’s ethics and compliance activities. Following the adoption of the 2010 Leadership Statement calling for greater transparency, accountability and ethical behaviour within and industry framework of self-regulation, she took the lead of activities including the creation of the EFPIA e4ethics platform and the development of the EFPIA Disclosure Code. She is acting as the Chief Ethics & Compliance Officer at EFPIA.

In 2015, she was asked to take the role of Ambassador to the Medical Communities, coordinating EFPIA’s relationships with medical & scientific societies, including learned societies, also through professional communities within the pharmaceutical companies that interact with medical communities.

11:45 am

Current Initiatives of the Trade Associations

As member of the Innovative Medicines Canada team and the Executive Director of Ethics and Compliance, Chrisoula Nikidis is responsible for the Code of Ethical Practices and related issues. Her key responsibilities include maintaining and updating the Code, managing the Code education program, answering Code related questions, offering guidance on the application of the Code while providing expertise on industry practices. Included in her responsibilities is advice and support to the President of Innovative Medicines Canada in matters that pertain to the International Federation of Pharmaceutical Manufacturers Association (IFPMA) and the Code Compliance Network.

Pedro Caridate de Freitas: Professor at the College of Law of Universidade de Lisboa since 1996, where he is responsible for and lectures on History of Portuguese Law, Roman Law and History of International Relations. Head of the Legal Department of Associação Portuguesa da Indústria Farmacêutica (the Portuguese Pharmaceutical Industry Association), where his duties encompass pharmaceutical, business, employment and administrative law issues. President of the History of Law and Political Thought Society of the College of Law of Universidade de Lisboa. Teacher of Master’s studies in Pharmaceutical Marketing at the Universidade Lusíada in Lisbon and Oporto Teacher of post-graduate studies in Pharmaceutical Marketing at the Instituto Superior de Economia e Gestão (ISEG) Member of the Portuguese Bar since 1997. He has published several studies in the field of History of Law and pharmaceutical legislation.

Ms Pickaert is the Deputy Director General of EFPIA, member of EFPIA’s General Management.

Since 2008, Ms Pickaert is coordinating EFPIA’s ethics and compliance activities. Following the adoption of the 2010 Leadership Statement calling for greater transparency, accountability and ethical behaviour within and industry framework of self-regulation, she took the lead of activities including the creation of the EFPIA e4ethics platform and the development of the EFPIA Disclosure Code. She is acting as the Chief Ethics & Compliance Officer at EFPIA.

In 2015, she was asked to take the role of Ambassador to the Medical Communities, coordinating EFPIA’s relationships with medical & scientific societies, including learned societies, also through professional communities within the pharmaceutical companies that interact with medical communities.

Roeland Van Aelst joined Johnson & Johnson in 1987 as a Medical Representative for Janssen Pharmaceutica. He held various positions of increasing responsibility in both sales and marketing and joined the Corporate Office of Health Care Compliance in May 2005 for the EMEA region with extension to Asia, Latin-America and Canada in 2008. In 2010 Roeland became responsible for EMEA & Canada cross sector. Since October 2012 he is the Regional Vice President – HCCO MD EMEA. Today he also fulfills the Chairman role of the MedTech Europe Ethics and Compliance Committee. He is a member of the board and a founding member of ETHICS, an association for Compliance professionals in the Health Care industry. Roeland is an active contributor to the Seton Hall/ Sience Poand the INSEAD training programs for Compliance professionals and is co-chairman for the International Pharmaceutical and Medical Device Compliance Congress.

Sofie Melis joined IFPMA in September 2016 and leads its Ethics and Compliance portfolio, which includes the global implementation and management of the IFPMA Code of Practice and the Ethics & Business Integrity Committee (eBIC). In her capacity, Sofie closely works with international stakeholders in building strategic partnerships that support public health goals worldwide. In the last 8 years of her career, Sofie has worked in corporate compliance for both Eli Lilly and Biogen Idec. Prior to that she held several roles in organisational learning & development in the banking, electronics and consulting industry. Just before joining the IFPMA, Sofie completed a one year assignment with the International Committee of the Red Cross as Head of HR Compliance. Sofie holds a master’s degree in Languages and Literature, a bachelor in Personnel Management, a post-master’s in Adult Education and a Certificate in International Compliance and Ethics.

Oscar Perdomo is a Director in PwC’s Pharmaceutical and Life Sciences practice with over 10 years of experience in the pharmaceutical and life sciences industry. Throughout his career Oscar has partnered with clients to deliver services related to strategy and business planning, business analytics, risk management, and project management.

Oscar has worked with many global pharmaceutical and life sciences companies to build and enhance their global compliance programs and to mitigate risks associated with interactions with healthcare professionals, anti-kickback laws, and anti-bribery / anti-corruption laws. In addition, Oscar has worked with clients to audit and monitor business activities, develop corrective action plans, draft and update policies and procedures, and train employees on global compliance issues and standards.